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Mar, 2018

sNDA Seeks to Expand the Indication of XTANDI to include Men with Non-metastatic CRPC
NEW YORK and TOKYO, March 19, 2018 – Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced today that a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) has been accepted for filing and granted Priority Review designation by t...

TOKYO – March 16, 2018 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced today that the European Medicines Agency (EMA) has validated and started the review process for Astellas’ application for a Type II Variation for enzalutamide to extend the overall indication to include patients with non-metastatic castration-resistant prostate cancer (CRPC) based...

Tokyo, March 9, 2018 - Astellas Pharma Inc. (President and CEO: Yoshihiko Hatanaka, “Astellas”) today announced that solifenacin succinate (generic name, “solifenacin”) oral suspension received approval in Europe for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 2 to 18 years. This approval was received in European 31 countries including the Netherlands which w...